Tokyo Thermo Fisher Scientific フルタイム

医療機器、体外診断用医薬品、動物用医薬品、研究用試薬(消耗品、機器含む)に係る品質保証業務

職務内容:

他の品質保証担当者と連携し、Quality Manage System (QMS)の運営、維持管理の実施していただきます 。

・QMS関連文書の新規作成及び改訂

・関係部門との協働による新製品の市場上市計画の策定と実行

・法定表示ラベルの作成、改定

・製造販売開始および変更時におけるリスク分析の実施

・内部監査および供給業者の評価の実施

・国内製造委託業者の管理
・不具合発生時の海外製造所への報告、連携による原因調査、是正・予防処置、顧客報告の実施

・QMS適合性調査対応

・製品の製造販売承認/認証申請時のQMS適合性調査申請資料の作成、QMS適合性調査対応

必要とされる資格・経験

・医療機器又は体外診断用医薬品分野における3年以上の品質保証業務経験

・規制当局又は認証登録機関によるISO13485適合性調査対応経験

・ビジネスレベルの英語力(技術資料の読解、メール及び電話会議対応)

歓迎される資格・経験

・チームリーダー又はチームマネジメント経験(People managerであるかは問わない)

・当社研究用の各種機器・分析用試薬、または同業他社製品の知見

・SAP等各種ERPシステムの使用経験



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